Study on Intermittent Fasting and High-Intensity Interval Training Effects on Inflammation, Metabolism, and Microbiome in Adults with Metabolic Syndrome

What this Trial Is About

Researchers are evaluating the effects of intermittent fasting, alone and combined with high-intensity interval training, on inflammation and metabolism in adults with obesity and metabolic syndrome. This randomized controlled pilot study aims to find out if these interventions reduce chronic inflammation, measured by hsCRP, in patients with metabolic syndrome compared to healthy controls. The study is sponsored by the University of Erlangen-Nrnberg Medical School and includes adults aged 18 to 80 years. Participants are divided into five groups three intervention groups with metabolic syndrome who follow either alternate-day fasting, time-restricted eating, or time-restricted eating plus high-intensity interval training, all alongside regular Mediterranean diet advice. Two control groups include metabolic syndrome patients and healthy individuals both receiving only Mediterranean diet advice. The intervention lasts 3 months, followed by a 3-month follow-up phase. During the 6-month study, participants attend six in-person visits and two phone visits for assessments and nutritional counseling. Researchers will measure inflammatory and metabolic markers, body composition, blood pressure, liver fat, and the composition of intestinal, oral, and skin microbiomes. The main outcome is the change in hsCRP from enrollment to the end of the 3-month intervention. Safety and adherence are monitored throughout the study.

Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome